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NCT Number: NCT06698692

Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma

Clinical data of patients with synchronous radiotherapy for esophageal cancer in the Department of Radiology of Jiangsu Provincial People's Hospital were collected. Patients were divided into trilaciclib group (34 cases) and control group (169 cases) based on whether trilaciclib was used or not. Patients in the trilaciclib group were given trilaciclib before each chemotherapy treatment. Propensity score matching (PSM) was used to balance the baseline characteristics between the two groups on a 1:1 ratio. After pairing, the rates of bone marrow suppression and other adverse events were compared between the two groups.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location status: Recruiting

Location contact

Xiaojie Xia

CONTACT

86+87373012 ext. 025

Xiaolin Ge

PRINCIPAL_INVESTIGATOR

Xiaolin Ge, PHD

CONTACT

[email protected]

87373012

About this study

chemoradiotherapy-induced myelosuppression (CIM) is the most common adverse event of concurrent chemoradiotherapy for esophageal cancer, often leading to reduction, delay or even cessation of chemotherapeutic agents. Clinical treatments for CIM mainly include various hematopoietic growth factors and blood transfusion. However, these interventions target only a single spectrum of blood cells and are susceptible to concomitant adverse events such as bone pain, thrombosis, and fever. Trilaciclib is a potent, transient, reversible CDK4/6 inhibitor and is the world's first innovative drug with lineage-wide myeloprotective effects. Its use in esophageal cancer has not been reported yet. In this study, we investigated the clinical efficacy and safety of trilaciclib in preventing myelosuppression in concurrent chemoradiotherapy for esophageal cancer for the first time.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥18 years;
  • pathological diagnosis of esophageal squamous cell carcinoma;
  • failure to undergo surgical treatment;
  • completion of definitive chemoradiotherapy or chemoradiotherapy combined with immunotherapy.

Exclusion criteria

  • history of other malignant tumors;
  • difficulty in follow-up;
  • insufficient clinical information.

Treatment and study plan

Trilaciclib Injection [Cosela]

Drug

Trilaciclib Combined chemoradiotherapy

Primary outcomes

  1. Incidence of grade ≥3 neutropenia

    Time frame: during Trilaciclib plus chemotherapy assessed up to 1 years

    Incidence of grade ≥3 neutropenia

Secondary outcomes

  1. Incidence of Adverse Events

    Time frame: during Trilaciclib plus chemotherapy assessed up to 1 years

    The incidence of Adverse Events according to Common Terminology Criteria for Adverse Events

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaolin Ge, PHD

CONTACT

[email protected]

86+83714511 ext. 025

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

Real-world Assessment of Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma

Acronym: COSELA

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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